Use of Pancreatic Enzymes in Short Bowel Syndrome (SBS)
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|ClinicalTrials.gov Identifier: NCT03097029|
Recruitment Status : Completed
First Posted : March 31, 2017
Results First Posted : February 10, 2020
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Short Bowel Syndrome||Drug: Pancreatic Enzyme||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Pancreatic Enzymes in Short Bowel Syndrome|
|Actual Study Start Date :||March 24, 2017|
|Actual Primary Completion Date :||February 1, 2019|
|Actual Study Completion Date :||February 1, 2019|
Experimental: Pancreatic Enzymes
All subjects in this study will have exposure to therapy with pancreatic enzymes for a period of about ten days.
Drug: Pancreatic Enzyme
All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.
Other Name: Creon
- Change in Coefficient of Fat Absorption [ Time Frame: Up to 10 days ]Coefficient of fat absorption (CFA) measures the amount of fat excreted in the stool compared to how much fat was consumed over the course of 72 hours. This is a measure of fat absorption. CFA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CFA values at each timepoint was the primary outcome.
- Change in the Coefficient of Nitrogen Absorption [ Time Frame: Up to 10 days ]Coefficient of nitrogen absorption (CNA) measures the amount of nitrogen excreted in the stool compared to how much nitrogen was consumed in a 72 hour period. This is a measure of protein absorption. CNA was measured at baseline off of pancreatic enzymes and then again while on ten days of pancreatic enzyme supplementation. The change between CNA values at each timepoint was a study outcome.
- Change in Malabsorption Blood Test [ Time Frame: Up to 10 days ]This test will only be performed on subjects 18 years or older. This an isotope test. Subjects consume a high fat shake with two labeled fats. They have blood tests measured at baseline and then every 1 hour for 8 hours to check for serum levels of labeled fats. This helps determine how well the labeled fats are being absorbed by the intestine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097029
|United States, Pennsylvania|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Natalie Terry, MD, PhD||Children's Hospital of Philadelphia|